Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

NCT01132274 | Completed Phase 4 DMC

• 1 other identifier: UCSC210210
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 6

Brief Summary

Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus exposing patients to ionizing radiations with an additional risk of cancer. The feasibility and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter, randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically significant reduction of the exposure to ionizing radiations compared with conventional ablation techniques. NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction of ionizing radiation exposure for both the patient and the operator.

Conditions

Supraventricular Tachycardias

Keywords

Supraventricular arrhythmia catheter ablation

Outcome Measures

Primary Outcomes (1)

• reduction of ionizing radiation exposure

  the NO-PARTY trial was designed to compare a non-fluoroscopic catheter ablation guided by the EnSite NavXTM mapping system with conventional catheter ablation for supraventricular tachyarrhythmias in terms of ionizing radiation exposure for both the patient and the operator

  1 day (radiation exposure will be evaluated at the end of procedure)

Secondary Outcomes (2)

• Cost-Effectiveness

  at 1 year

• Cost-Effectiveness

  at 2 years

Study Arms (2)

Conventional catheter ablation

ACTIVE COMPARATOR

Radiofrequency catheter ablation through fluoroscopic guidance

Procedure: Radiofrequency catheter ablation

Non-fluoroscopic catheter ablation

EXPERIMENTAL

Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system

Procedure: Radiofrequency catheter ablation

Interventions

Radiofrequency catheter ablation PROCEDURE

Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.

Conventional catheter ablation

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• male and female patients between 14 and 50 years of age who have received an indication to radiofrequency catheter ablation of supraventricular arrhythmias according to current guidelines.

You may not qualify if:

• atrial fibrillation or non isthmus-dependent atrial flutter
• pregnancy
• hematological contraindications to ionizing radiation exposure
• presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Abbott Medical Devices: collaborator
• CNR Institute of Clinical Physiology, Pisa, Italy: collaborator

Study Sites (6)

Santa Maria della Misericordia - A.O. di Perugia

Perugia, PG, 06156, Italy

Location

Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Location

CNR, Institute of Clinical Physiology, Fondazione G. Monasterio

Pisa, PI, Italy

Location

Institute of Cardiology; Presidio Ospedaliero Santa Chiara

Trento, TN, Italy

Location

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan

Milan, 20138, Italy

Location

Catholic University of the Sacred Heart

Rome, 00198, Italy

Location

Related Publications (2)

• Casella M, Dello Russo A, Pelargonio G, Bongiorni MG, Del Greco M, Piacenti M, Andreassi MG, Santangeli P, Bartoletti S, Moltrasio M, Fassini G, Marini M, Di Cori A, Di Biase L, Fiorentini C, Zecchi P, Natale A, Picano E, Tondo C. Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients. Cardiol Young. 2012 Oct;22(5):539-46. doi: 10.1017/S1047951112000042. Epub 2012 Feb 13.

  PMID: 22325367 BACKGROUND

• Casella M, Dello Russo A, Pelargonio G, Del Greco M, Zingarini G, Piacenti M, Di Cori A, Casula V, Marini M, Pizzamiglio F, Zucchetti M, Riva S, Russo E, Narducci ML, Soldati E, Panchetti L, Startari U, Bencardino G, Perna F, Santangeli P, Di Biase L, Cichocki F, Fattore G, Bongiorni M, Picano E, Natale A, Tondo C. Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: the NO-PARTY multicentre randomized trial. Europace. 2016 Oct;18(10):1565-1572. doi: 10.1093/europace/euv344. Epub 2015 Nov 10.

  PMID: 26559916 DERIVED

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Michela Casella, MD, PhD

  Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: May 28, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

IT (6)